NCT02781857已完成不适用
Exhaled Breath Analysis by Secondary Electrospray Ionization - Mass Spectrometry (SESI-MS) in Patients With Lung Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 309
- 试验地点
- 2
- 主要终点
- Concentration of volatile organic compounds (VOCs) in the exhaled breath will be analysed using mass spectrometry
研究概览
简要总结
To answer the question whether a disease specific profile of breath in patients with lung cancer can be detected by an untargeted metabolomic study using exhaled breath analysis by mass spectrometry.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed lung cancer based on cytological or histological analysis.
- •Group A: any type of lung cancer eligible for surgical resection (up to TNM stage IIIa).
- •Group B: any type of lung cancer (small-cell carcinoma, non-small-cell carcinoma) not amenable for surgical resection.
- •Group C: matched controls.
- •Age between 18 and 85 years at study entry
排除标准
- •Another 'active' secondary malignant disease (e.g. breast cancer, colon carcinoma) in group A and B, presence of any active malignant disease in group C (based on personal information).
- •Acute inflammatory disease (e.g. common cold) within the last 4 weeks.
- •Any other acute lung disease which affects breath measurements
- •Acute or chronic hepatic disease.
- •Renal failure or renal replacement therapy.
结局指标
主要结局
Concentration of volatile organic compounds (VOCs) in the exhaled breath will be analysed using mass spectrometry
时间窗: 1 day, single measurement
The primary outcome will be the lung cancer specific mass spectrometric profile of VOCs of exhaled breath analysis (markers of lung cancer in exhaled breath).
次要结局
- Group A: Concentration of volatile organic compounds (VOCs) in the exhaled breath will be analysed using mass spectrometry before and after lung cancer surgery(Group A: 2 measurements on 2 different days; Day 1: 1. measurement (before surgery), Day 2: (6-12 weeks after surgery): 2. measurement)
研究者
研究点 (2)
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